At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed non-squamous NSCLC
- ✓Treated brain metastases with no evidence of progression or hemorrhage after treatment, confirmed by clinical exam and brain imaging (MRI or CT)
- ✓Appropriate for first- or second-line systemic therapy for advanced NSCLC
- ✓Age ≥18 years
- ✕Prior treatment with investigational or marketed anti-angiogenic agent
- ✕Brain biopsy or neurosurgical procedure within 3 months prior to Day 1
- ✕Progressive neurologic symptoms
- ✕Gross hemoptysis within 3 months prior to Day 1
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Bevacizumab in Combination With First- or Second-Line Therapy in Subjects With Treated Brain Metastases Due to Non-Squamous Non-Small Cell Lung Cancer
In Brief
A Phase 2 clinical trial evaluating bevacizumab, First-Line Chemotherapy Agents, and 1 other intervention for Non-Small Cell Lung Cancer and Brain Neoplasms. Completed, enrolled 115 participants.
Detailed Summary
This was an open-label, multicenter, single-arm, Phase II trial of bevacizumab combined with first- or second-line therapy in patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with previously treated central nervous system (CNS) metastases. A total of 115 patients enrolled in the study.
Study Details
Timeline
Interventions
15 mg/kg intravenously (IV) on the first day of each 21- to 28-day cycle (± 4 days); the interval between infusions could not be \< 17 days, but could extend beyond 28 days if chemotherapy was delayed to allow recovery from toxicity.
Carboplatin, cisplatin, paclitaxel, docetaxel, gemcitabine, vinorelbine, pemetrexed, or erlotinib administered on Day 1 of every 21-day cycle except gemcitabine, which was administered on Days 1 and 8 of every cycle. Agents were administered as a platinum doublet, or erlotinib alone, at the investigator's discretion. Chemotherapy was administered for a total of 6 planned cycles (up to 8 cycles with prior approval from the Medical Monitor), followed by single-agent bevacizumab therapy. The chemotherapy regimen was to be consistent throughout the study. Erlotinib was administered orally daily. All agents were dosed and administered per institutional standards using the respective package insert as a guideline.
Erlotinib, pemetrexed, docetaxel, or chemotherapy at the investigator's discretion. Erlotinib was administered orally daily; pemetrexed and docetaxel were administered IV on Day 1 of every 21-day cycle. Single-agent bevacizumab therapy could be continued at the investigator's discretion if the second-line agent was discontinued. All agents were dosed and administered per institutional standards using the respective package insert as a guideline.